RA Manager, Global Labeling

Your Key Responsibilities:

Your responsibilities include, but not limited to:

• Performs tasks assigned as per applicable procedures (e.g., GOPs, SOPs, WIs) This includes, but is not limited to:
• CDS and core English SmPC/PIL/Label (in line with CDS and all relevant HA signals) preparation and maintenance
• Signal Detection & Evaluation: perform external signal detection by monitoring HA websites and/or the reference product label, and enter identified signals into the CDS & SD database.
• Evaluate signals from any source for their impact on patient safety, and decide on actions to be taken to mitigate related risk. Organization of translations if needed and readability testing of package leaflets
• Maintain core SmPC/PIL/Label based on CMC or administrative changes . Define submission strategy for EU and interact with HAs as needed . Ensure in-time hand-over of variation package or response documents to submission teams
• Ensure update of internal databases/RIMS . Collaborate with Regulatory Associates and Specialists for assigned tasks to enable timely submissions . Prepare and maintain SOPs/WIs/guidelines as assigned
• Maintain documentation and perform administrative actions as required . Support to country organization as appropriate . Support compliance/performance reporting and oversight . Support labelling projects, audit and inspections, and other specific tasks as assigned
• Represent global labelling team in internal (safety) boards and present specific topics when needed

Key performance indicators:

• Assure all required CDS and labelling documents are prepared with utmost quality and timely submitted.
• Assure acceptability of CDS, labelling documents and submission strategies towards Health Authorities. No recalls due to errors in SmPC/PL. KPI number for non-justified DLs to be applied (justified e.g.: on purpose/strategy, interpretation of guidelines).
• Minimize audit and inspection findings, escalations due to errors in global documents as well as labelling related litigation/reputation risks. Assure potential critical audit/inspection findings are timely escalated.
• 4-5 years in role to develop depth in competencies on product ownership from a labelling perspective, scope internal/external environment to bring in process efficiencies and Audit/Inspection experience.
• Ensure compliance with internal processes and policies.

• Post Graduate degree, preferably in natural science (chemistry, pharmacy, biology or equivalent) or Healthcare Professional
• 10 years of experience in global labelling or other regulatory affairs functions (preferably 5+ years in Global Labeling)
• • Good understanding of drug safety information
• Simplifies and standardizes routine activities to the extent possible, while not compromising on scientific product knowledge and evaluations
• Ability to effectively collaborate with cross-functional teams in a matrix environment
• Organizational awareness (inter-relationship of departments, business priorities)
• Sound understanding of medical and scientific terminologies

Skills :

• Data Analysis.
• Documentation Management.
• Lifesciences.
• Project Management.
• Regulatory Compliance.

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more

With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported

Join us